Healthcare Industry News: orphan drug designation
News Release - May 29, 2018
TrioxBio Announces Fast Track Designation Granted by U.S. FDA to Raviten(R) for the Treatment of Intradialytic HypotensionPhase II clinical trials in patients undergoing hemodialysis to be initiated in Q4, 2018
NEWARK, Delaware, May 29, 2018 -- (Healthcare Sales & Marketing Network) -- TrioxBio Inc., a clinical-stage biopharmaceutical company specializing in the development of drugs to treat diseases and medical conditions related to the pathological overproduction of nitric oxide (NO), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RavitenŽ (MTR-107) for the reduction in hospitalizations or death in patients with end-stage renal disease undergoing hemodialysis and predisposed to developing intradialytic hypotension.
"Intradialytic hypotension is a serious and frequent complication of hemodialysis; associated with increased morbidity and mortality in hemodialysis patients. It is a high unmet medical need and has no FDA-approved therapies available. The Fast Track designation will enable us to work closely with the FDA to accelerate our efforts to potentially provide an impactful solution for these vulnerable patients," said Shlomo Sadoun, CEO of TrioxBio.
The Company plans to initiate Phase II clinical trials for RavitenŽ in the United States later this year.
About Intradialytic Hypotension
Intradialytic hypotension (IDH) is a serious and frequent complication of hemodialysis therapy, associated with increased morbidity and mortality in end-stage renal disease patients receiving maintenance hemodialysis.,
IDH is a high unmet medical need, as there is no FDA-approved therapies available to-date.
- Flythe JE, et al. Association of Mortality Risk with Various Definitions of Intradialytic Hypotension. J Am Soc Nephrol. 2015 26:724-734.
- Chou JA, et al. Intradialytic hypotension, blood pressure changes and mortality risk in incident hemodialysis patients. Nephrol Dial Transplant. 2018 33:149-159.
RavitenŽ (MTR-107) is an injectable solution of S-ethylisothiouronium diethylphosphate under development for the management of intradialytic hypotension. The drug has been shown in preclinical and exploratory clinical trials to inhibit the inducible Nitric Oxide synthase (iNOS), endothelial NOS (eNOS) and neuronal NOS (nNOS), thereby controlling overproduction of Nitric Oxide; and to normalize low blood pressure in patients suffering from intradialytic hypotension, as well as other low blood pressure conditions.
Following the recent grant of orphan drug designation and Fast Track status by the FDA, the Company plans to initiate Phase II clinical trials in patients undergoing hemodialysis in the 4th quarter of 2018.
About Fast Track
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
TrioxBio Inc. is a clinical-stage biopharmaceutical company specializing in the development of compounds to treat diseases and medical conditions related to the pathological overproduction of nitric oxide (NO). The Company's lead drug candidate, RavitenŽ (MTR-107), is currently under development for the management of intradialytic hypotension (IDH).
In addition to RavitenŽ for the management of IDH, TrioxBio has supplementary drug candidates, based on the same active ingredient, for the treatment of vasoplegic syndrome, cluster headache and migraine.
For more information on TrioxBio, please visit http://www.trioxbio.com/
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.